EP3976171A1 - Implantierbarer stimulator mit externer vorrichtung - Google Patents

Implantierbarer stimulator mit externer vorrichtung

Info

Publication number
EP3976171A1
EP3976171A1 EP20814344.6A EP20814344A EP3976171A1 EP 3976171 A1 EP3976171 A1 EP 3976171A1 EP 20814344 A EP20814344 A EP 20814344A EP 3976171 A1 EP3976171 A1 EP 3976171A1
Authority
EP
European Patent Office
Prior art keywords
user
stimulator
sensor
apnea event
electrical stimulation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP20814344.6A
Other languages
English (en)
French (fr)
Other versions
EP3976171A4 (de
Inventor
Peter DASSOS
Benjamin Peter JOHNSTON
Nathan Liu
Sakeena DE SOUZA
Mark Neil Phillips
Genevieve Claire MADAFIGLIO
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Resmed Pty Ltd
Original Assignee
Resmed Pty Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Resmed Pty Ltd filed Critical Resmed Pty Ltd
Publication of EP3976171A1 publication Critical patent/EP3976171A1/de
Publication of EP3976171A4 publication Critical patent/EP3976171A4/de
Pending legal-status Critical Current

Links

Classifications

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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/3606—Implantable neurostimulators for stimulating central or peripheral nerve system adapted for a particular treatment
    • A61N1/3611—Respiration control
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    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3601—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of respiratory organs
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    • A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
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    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
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    • A61N1/36139—Control systems using physiological parameters with automatic adjustment
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    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
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    • A61N1/36128—Control systems
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    • A61N1/3615—Intensity
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    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
    • A61N1/36128—Control systems
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    • A61N1/36167—Timing, e.g. stimulation onset
    • A61N1/36171—Frequency
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Definitions

  • the present disclosure relates to treatment of respiratory-related disorders and more specifically to systems and methods with implantable stimulators and corresponding external devices for addressing one or more types of apnea events.
  • a method for aiding a user includes receiving, from one or more sensors, data associated with an airway of the user. The method also includes analyzing the data to determine if the user is experiencing an apnea event, if the user is about to experience and apnea event, if the user is no longer experiencing an apnea event, or any combination thereof. The method further includes in response to a determination that the user is experiencing an apnea event or the user is about to experience an apnea event, causing a stimulator to provide electrical stimulation to a portion of the user to aid in stopping or preventing the apnea event.
  • control system In response to a determination that (i) the user is experiencing an apnea event or (ii) the user is about to experience an apnea event, the control system causes the transmitter to communicate with the receiver such that the stimulator provides the electrical stimulation to aid in stopping or preventing the apnea event.
  • a method includes receiving, from one or more sensors, data associated with an airway of the user. The method also includes determining that the user is currently experienced an apnea event based at least in part on the received data. The method further includes in response to determining that the user is currently experiencing an apnea event, causing a stimulator to provide electrical stimulation, at a first intensity level, to one or more muscles of the user that are adjacent to the airway to aid in stopping the apnea event.
  • the control system further analyzes the generated data to determine if the user is currently experiencing a second type of apnea event that is different than the first type of apnea event.
  • the control system causes the first stimulator to provide electrical stimulation to one or more muscles of the user that are adjacent to the throat of the user to aid in stopping the first type of apnea event.
  • the control system causes the second stimulator to provide electrical stimulation to the diaphragm of the user to aid in stopping the second type of apnea event.
  • FIG. 1 A is a diagram that illustrates an overview of a respiratory system of a user
  • FIG. 3B is a perspective view of the system of FIG. 3 A where the external device is wom/donned by the user;
  • the respiratory system 12 of the user 10 facilitates gas exchange.
  • the nose 50 and mouth 60 of the user 10 form the entrance to the airways of the user 10.
  • the airways include a series of branching tubes, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs of the user 10.
  • the prime function of the lungs is gas exchange, allowing oxygen to move from the inhaled air into the venous blood and carbon dioxide to move in the opposite direction.
  • the trachea divides into right and left main bronchi, which further divide eventually into terminal bronchioles.
  • the bronchi make up the conducting airways, and do not take part in gas exchange. Further divisions of the airways lead to the respiratory bronchioles, and eventually to the alveoli.
  • the alveolated region of the lungs is where the gas exchange takes place, and is referred to as the respiratory zone.
  • Obstructive Sleep Apnea is a form of Sleep Disordered Breathing (SDB) and is characterized by events including occlusion and/or obstruction of the upper air passage during sleep.
  • OSA results from a combination of an abnormally small upper airway and the normal loss of muscle tone in the region of the tongue, soft palate, and posterior oropharyngeal wall during sleep.
  • the condition causes the affected patient to stop breathing for periods typically of 30 to 120 seconds in duration, sometimes 200 to 300 times per night.
  • OSA often causes excessive daytime somnolence, and it may cause cardiovascular disease and brain damage.
  • the syndrome is a common disorder, particularly in middle aged overweight males, although a person affected may have no awareness of the problem.
  • Respiratory failure is an umbrella term for respiratory disorders in which the lungs are unable to inspire sufficient oxygen or exhale sufficient CO2 to meet the user’s needs. Respiratory failure may encompass some or all of the following disorders.
  • a user with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath on exercise.
  • Obesity Hyperventilation Syndrome is the combination of severe obesity and awake chronic hypercapnia, in the absence of other known causes for hypoventilation. Symptoms include dyspnea, morning headache and excessive daytime sleepiness.
  • FIG. 2 a block diagram of a system 100 for aiding a user (e.g., user 10 in FIGS. 1 A and IB) is shown.
  • the system 100 can aid the user 10 (i) in breathing while sleeping, (ii) in breathing while awake, (iii) in opening an airway of the user, (iv) in starting or increasing a breathing function (e.g., contracting a diaphragm), (v) or any combination thereof.
  • the system 100 aids the user 10 by causing one or more muscles of the user 10 to contract to (i) open an airway of the user 10, (ii) to cause the user 10 to inhale air (e.g., breathing effort), or (iii) both.
  • the system 100 includes one or more of: a housing 102, a stimulator 104, a receiver 108, a transmitter 110, a motion sensor 112, a magnetic field generator 114, a microphone 116, a conductance sensor 118, a heart rate sensor 120, an air flow sensor 122, a photoplethysmography (PPG) sensor 124, one or more other sensors 126 (e.g., EKG sensor, EEG sensor, EMG sensor, blood flow sensor, respiration sensor, pulse sensor, etc.), a memory 128, a control system 130, a battery 132, an external device 150, or any combination(s) thereof.
  • PPG photoplethysmography
  • the system 100 can include any portion of and any combination of these elements and the elements can be combined in various different arrangements (e.g., physical and/or wireless) and/or housings.
  • Some of the elements of the system 100 are positioned in the user 10 (e.g., implanted in the user 10) and others of the elements of the system 100 are positioned outside the user 10 (e.g., wom/donned by the user 10).
  • One or more of the elements of the system 100 that are positioned in the user 10 can be so positioned by being injected into the user 10 using, for example, a syringe with a hypodermic needle attached thereto.
  • one or more of the elements of the system 100 that are positioned in the user 10 can be so positioned by being surgically placed therein (e.g., cutting open the skin and positioning the element(s) therein and suturing the skin closed).
  • the stimulator 104 is positioned in the user 10 such that one or more electrical leads 105 of the stimulator 104 are positioned adjacent to one or more muscles of the user 10 and/or one or more nerves of the user 10 that are connected to the one or more muscles of the user 10.
  • the one or more electrical leads 105 includes a first electrical lead 105 that is positioned to stimulate a first one of the one or more muscles and/or a first one of the one or more nerves.
  • a second electrical lead 105 is positioned to stimulate a second one of the one or more muscles and/or a second one of the one or more nerves.
  • the first electrical lead 105 provides the electrical stimulation at a first frequency and the second electrical lead 105 provides the electrical stimulation at a second frequency that is different from the first frequency. In some implementations, the first electrical lead 105 provides the electrical stimulation at a first intensity and the second electrical lead 105 provides the electrical stimulation at a second intensity that is different from the first intensity.
  • the stimulator 104 may be leadless, with the stimulator body being conductive and the ends of the body acting as electrodes.
  • the stimulator 104 is capable of delivering electrical and/or magnetic stimulation to the user 10 to aid in causing the one or more muscles of the user 10 to contract.
  • the contraction of the one or more muscles of the user 10 can aid in opening an airway of the user 10.
  • the contraction can alternatively or additionally aid in causing the user 10 to have breathing effort (e.g., causing the diaphragm to draw/suck in air).
  • the stimulator 104 includes or is an electrical conductor (e.g., one or more electrically conductive wires with or without a portion being electrically insulated).
  • the stimulator 104 includes the one or more electrical leads 105, which are capable of carrying and/or flowing and delivering electrical current to the one or more muscles and/or one or more nerves of the user 10.
  • the electrical current can be supplied by the battery 132 or other power source that is directly and physically connected to the stimulator 104.
  • the battery 132 can be rechargeable. In some implementations, the battery 132 can be recharged by the magnetic field generator 114 and/or the external device 150. Alternatively to the stimulator 104 including the battery 132, in some implementations, the electrical current is supplied wirelessly by the magnetic field generator 114 (which can be included in the external device 150) directly to the electrical conductor(s).
  • the stimulator 104 only includes one or more electrically conductive wires, with or without a portion being electrically insulated.
  • the stimulator 104/wire has a length between about 1 millimeter and about 100 centimeters; between about 1 millimeter and about 100 millimeters; between about 1 millimeter and about 10 millimeters; or any length therebetween.
  • the stimulator 104/wire has a diameter between about 0.01 millimeters and about 5 millimeters; between about 0.1 millimeter and about 2 millimeters; between about 0.1 millimeter and about 1 millimeter; or any diameter therebetween.
  • the size and shape of the stimulator 104 can be selected to permit the injection of the stimulator 104 into the user 10 via a syringe with an attached hypodermic needle.
  • the stimulator 104 is directly positioned in the user 10.
  • the housing 102 is not required.
  • the stimulator 104 or a portion thereof is coupled to the housing 102 (e.g., positioned at least partially therein) and the housing 102 (with the stimulator 104 coupled thereto) is positioned in the user 10.
  • the housing 102 can have the shape of an elongated pill (or any other shape) that is conducive to being injected into the user 10 using, for example, a syringe with a hypodermic needle attached thereto.
  • the housing 102 electrically insulates at least a portion of the stimulator 104 (e.g., the entire stimulator 104 except for the one or more electrical leads 105 or conductive ends) from surrounding tissue of the user 10.
  • the receiver 108 can be coupled to the housing 102 and placed into the user 10.
  • PPG photoplethysmography
  • coupled to the housing 102 it is meant that the element coupled to the housing 102 is completely incased within the housing 102, attached to an exterior surface of the housing 102, partially protruding from one or more openings in the housing 102, directly or indirectly attached to the housing 102, or any combination thereof.
  • the stimulator 104 and the receiver 108 are coupled to the housing 102 and positioned in the user 10.
  • the stimulator 104, the receiver 108, and the PPG sensor 124 are coupled to the housing 102 and positioned in the user 10.
  • the stimulator 104, the receiver 108, the PPG sensor 124, the memory 128, and the control system 130 are coupled to the housing 102 and positioned in the user 10.
  • Various other combinations of elements being coupled to the housing 102 and positioned in the user 10 are contemplated.
  • the motion sensor 112 can be coupled to the housing 102 and positioned in the user 10. Alternatively, the motion sensor 112 can be separate from the housing 102 and/or the stimulator 104 and positioned in the user 10. In such implementations where the motion sensor 112 is positioned in the user 10, the motion sensor 112 can be positioned adjacent to the airway of the user 10 to generate data associated with movements or lack of movements of the airway that indicate breathing or a lack thereof. The positioning of the motion sensor 112 can be in the throat 20 (FIGS. 1 A and IB) of the user 10, the thoracic cavity 30, the abdominal cavity 40, or a combination thereof.
  • the system 100 can include the microphone 116, the conductance sensor 118, the heart rate sensor 120, the air flow sensor 122, the PPG sensor 124, the other sensor(s) 126, or any combination thereof, where such sensors or portion thereof is in the user 10 and/or coupled to the external device 150 in the same, or similar, fashion as described above for the motion sensor 112.
  • the system 100 includes the heart rate sensor 120 coupled to the external device 150 such that the heart rate sensor 120 is positioned adjacent to the chest of the user 10 when the external device 150 is worn by the user 10 as a band/belt.
  • the heart rate sensor 120 is able to generate data that is indicative a heart rate and/or pulse of the user 10.
  • the one or more parameters of the stimulation are varied based on a measured response (e.g., using one or more of the sensors of the system 100) of the one or more muscles to the stimulation.
  • the modification to the parameters can be based on a continuous feedback loop by the control system 130 continuing to analyze the data generated by one or more of the sensors of the system 100 (e.g., the motion sensor 112, the air flow sensor 122, the PPG sensor 124, etc. or any combination thereof).
  • control system 130 is able to modify (e.g., in real-time, while the user is experiencing the same apnea event, after the user experiences an apnea event but before the user experiences another apnea event, etc.) one or more of the parameters based on the continued analysis.
  • the external device 150 can be in the form of a collar, a band, a belt, etc., or any combination thereof and worn/donned by the user 10.
  • the external device 150 includes a housing made entirely or at least partially from a stretchable material such that the external device 150 can be at least partially held close to the skin of the user 10 when worn.
  • the collar e.g., external device 150
  • the collar can include stretchable material so the collar is snug around the neck of the user 10 (without choking the user 10).
  • a PPG sensor 124 is included in the collar (e.g., external device 150)
  • the PPG sensor 124 can be held in close relationship to the neck of the user 10, which can aid in providing more accurate data from the PPG sensor 124.
  • the external device 150 can include any number of the elements of the system 100.
  • the transmitter 110, the motion sensor 112, the magnetic field generator 114, the microphone 116, the conductance sensor 118, the heart rate sensor 120, the photoplethysmography (PPG) sensor 124, the other sensor(s) 126, the memory 128, the control system 130, the battery 132, or any combination thereof is coupled to and/or positioned within the external device 150.
  • the external device 150 at least includes one or more of the sensors of the system 100, the magnetic field generator 114, the memory 128, the control system 130, and the battery 132.
  • the control system 130 executes a therapy parameter algorithm for the determination of one or more of the parameters (e.g., intensity, frequency, duration, etc.) of the stimulator 104.
  • the therapy parameter algorithm receives as an input the output(s) of one or more other algorithms described herein and outputs one or more values for the one or more parameters (e.g., intensity, frequency, duration, etc.) of the electrical stimulation provided by the stimulator 104.
  • the system 100 is shown as including one stimulator 104, one external device 150, and one battery 132, it is contemplated that the system 100 can include any number of stimulators 104 (e.g., one, two, three, five, ten, fifty, etc.), the system 100 can include any number of external devices (e.g., one, two, three, five, ten, fifty, etc.), and the system 100 can include any number of batteries 132 (e.g., one, two, three, five, ten, etc.).
  • the ratio of stimulators to external devices can be one-to-one or a different ratio.
  • two or more stimulators 104 can be controlled by and/or communicate with one external device 150.
  • the control system 130 executes a respiration event determination algorithm for the determination of the presence of respiration events in the user 10.
  • the respiration event determination algorithm is stored as instructions in the memory 128.
  • the stimulator 204 is the same as, or similar to, the stimulator 104 described herein in connection with FIG. 2.
  • the stimulator 204 is shown with two electrical leads 205 adjacent to one or more muscles of the user 10B, although any number of electrical leads 205 are contemplated (e.g., one electrical lead, three electrical leads, five electrical leads, ten electrical leads, etc.).
  • the stimulator may be leadless with the ends of the stimulator capsule acting as electrodes to deliver stimulation.
  • the coupling mechanism 260 includes a loop at one end of the external device 250 into which the opposite end of the external device 250 fits through and doubles back to secure to an outside surface of the external device 250 using, for example, hook and loop fasteners.
  • the coupling mechanism 260 aids in securing the external device 250 to the user 10B in a snug fashion.
  • the coupling mechanism 260 aids in securing the external device 250 to the user 10B in a loose fashion.
  • the external device 250 includes a sensor 275, a memory 228, a control system 230, and a battery 232.
  • the sensor 275 is the same as, or similar to, the motion sensor 112, the microphone 116, the conductance sensor 118, the heart rate sensor 120, the PPG sensor 124, the other sensor(s) 126, or any combination thereof.
  • the memory 228 is the same as, or similar to, the memory 128 described herein in connection with FIG. 2.
  • the control system 230 is the same as, or similar to, the control system 130 described herein in connection with FIG. 2.
  • the battery 232 is the same as, or similar to, the battery 132 described herein in connection with FIG. 2.
  • the external device 250 (and/or the stimulator 204) can also include one or more wireless control elements 235 such that the external device 250 and the stimulator 204 can wirelessly communicate with and/or wirelessly power the stimulator 204.
  • the one or more wireless control elements 235 can be imbedded/included in the control system 230 and/or be separate therefrom.
  • the external system 250 can include a transmitter that is the same as, or similar to, the transmitter 110 (and the stimulator 204 can include a receiver that is the same as, or similar to, the receiver 108), the magnetic field generator 114, a wireless control module, or any combination thereof.
  • the stimulator 204 itself (e.g., the electrically conductive wire forming at least a portion of the stimulator 204) serves as a wireless receiver without needing any other components.
  • the wireless control element 235 of the stimulator 204 is or includes a receiver (e.g., receiver 108) and the wireless control element 235 of the external device 250 is or includes a transmitter (e.g., transmitter 110).
  • the external device 250 can include other features to aid the user 10B in aligning the external device 250 when donning the external device 250.
  • a cutout 285 e.g., having a circular shape, a square shape, a triangular shape, a polygonal shape, etc. or any combination thereof
  • a cutout 285 in the external device 250 can indicate a location of the external device 250 that should be aligned with a specific part of the user’s anatomy (e.g., midline of the throat 20B) such that, for example, the sensor 275 is appropriately placed relative to the user 10B.
  • each of the external devices 350A, 350B includes a sensor 375, a memory 328, a control system 330, a battery 332, a coupling mechanism 360, and a wireless control element 335, which are the same as, or similar to, the sensor 275, the memory 228, the control system 230, the battery 232, the coupling mechanism 260, and the wireless control element 235 of the system 200 described in connection with FIGS. 3A and 3B.
  • the second external device 350B mainly differs in its size relative to the first external device 350A and the external device 250. Namely, the second external device 350B is larger to be wearable about a chest of the user IOC.
  • the first and second external devices 350A, 350B operate together and are coupled together (e.g., wirelessly and/or wired).
  • only one of the first and second external devices 350A, 350B includes the memory 328 and the control system 330. That is, for example, the second external device 350B (chest band) includes the memory 328, the control system 330, the sensor 375, and the battery 332, and the first external device 350A (collar) includes the sensor 375 and the battery 332.
  • the first external device 350A (collar) includes the memory 328, the control system 330, the sensor 375, and the battery 332, and the second external device 350B (chest band) includes the sensor 375 and the battery 332.
  • the control system 330 determines that the user IOC is currently experiencing the first type of apnea event, the control system 330 causes the first stimulator 304 A to provide electrical stimulation.
  • the electrical stimulation can be provided to one or more muscles and/or one or more nerves of the user IOC that are adjacent to the throat 20C of the user IOC.
  • the electrical stimulation can aid in stopping the first type of apnea event (e.g., by causing the one or more muscles in the throat 20C to contract and open the airway of the user IOC).
  • control system 330 determines that the user IOC is currently experiencing the first type of apnea event and the second type of apnea event at the same time, the control system 330 (i) causes the first stimulator 304 A to provide electrical stimulation to the one or more muscles and/or one or more nerves of the user IOC that are adjacent to the throat 20C of the user IOC and (ii) causes the second stimulator 304B to provide electrical stimulation to the diaphragm and/or one or more nerves connected to the diaphragm of the user IOC.

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EP20814344.6A 2019-05-31 2020-05-28 Implantierbarer stimulator mit externer vorrichtung Pending EP3976171A4 (de)

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US201962855487P 2019-05-31 2019-05-31
PCT/IB2020/055091 WO2020240480A1 (en) 2019-05-31 2020-05-28 Implantable stimulator with external device

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JP (1) JP7465896B2 (de)
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USD996623S1 (en) * 2020-09-11 2023-08-22 Ant5 Co., Ltd. Subdural sensor

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US5233983A (en) * 1991-09-03 1993-08-10 Medtronic, Inc. Method and apparatus for apnea patient screening
US6928324B2 (en) * 2002-02-14 2005-08-09 Pacesetter, Inc. Stimulation device for sleep apnea prevention, detection and treatment
DE602004014281D1 (de) * 2003-08-18 2008-07-17 Cardiac Pacemakers Inc Steuerungsgerät für unregelmässige atmung
WO2010059839A2 (en) * 2008-11-19 2010-05-27 Inspire Medical Systems, Inc. Method of treating sleep disordered breathing
CA2780096A1 (en) * 2009-11-10 2011-05-19 Imthera Medical, Inc. System for stimulating a hypoglossal nerve for controlling the position of a patient's tongue
EP2788081A4 (de) * 2011-12-07 2015-06-10 Otologics Llc Vorrichtung zur kontrolle von schlafapnoe
WO2014016686A2 (en) 2012-07-26 2014-01-30 Adi Mashiach Insert tool for selectively powering an implant unit
CN105283219A (zh) 2013-04-05 2016-01-27 瓦萨姆·艾哈迈德 用于气流诊断和恢复的设备和方法
WO2017087681A1 (en) * 2015-11-17 2017-05-26 Inspire Medical Systems, Inc. Microstimulation sleep disordered breathing (sdb) therapy device

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JP2022535804A (ja) 2022-08-10
US20220233857A1 (en) 2022-07-28
KR20220075193A (ko) 2022-06-07
EP3976171A4 (de) 2023-06-14
JP7465896B2 (ja) 2024-04-11

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